Kornimate/medical-research-clean huggingface dataset:
rwe study in the treatment of cervical lesions of various etiology

Conditions: Cervical Lesion; Vaginal Bleeding

Summary: the aim of the study was to assess the post-market performance and tolerability of cerviron® ovules in the treatment and management of cervical lesions of different etiologies. the study included clinical data related to aspect of lesions performed during routine colposcopy exams, the degree of re-epithelialization of the cervical mucosa, vaginal ph, pain level, and vaginal bleeding level.

this study is an observational, post-marketing study conducted between may-july 2021. the aim of the study was to assess the post-market performance and tolerability of cerviron® ovules in the treatment and management of cervical lesions of different etiologies. the secondary objective of this clinical investigation is the assessment of performance of the medical device by clinical exam and patients' degree of satisfaction related to the use of the medical device. the study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion.

Eligibility criteria:
inclusion criteria: * patients with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions. * patients with either of the following medical history: trauma of the cervix, pain, bleeding after sexual intercourse, postpartum injuries or postoperative cervical lesions. exclusion criteria: * patients with cervical cancer. * patients with vulvar cancer

Keywords: cervical ectropion vaginal discharge cervix lesion
resection or ablation of small kidney tumors

Conditions: Kidney Cancer

Summary: ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign pad compared to partial nephrectomies in small kidney cancer lesions. the purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. we will also compare the oncological outcomes, including survival and recurrence of kidney cancer.

kidney cancer represents approximately 2-3% of all cancer cases, with about 400,000 new cases and 175,000 deaths worldwide in 2018. in sweden, about 1,200 new cases of kidney cancer are detected each year. the most common age for diagnosis is between 60 and 80 years, and it is more prevalent in men than in women. many cases are incidentally discovered during imaging studies for unrelated issues. there has been an increase in incidentally detected tumors in sweden, from 43% in 2005 to 69% in 2021. nephron-sparing surgery, i.e., partial nephrectomy, is recommended for preserving kidney function in localized tumors. ablative treatments are recommended for patients with significant comorbidities, multiple tumors, a single kidney, or other situations where surgery is not considered suitable. prior to treatment, a biopsy is usually performed to confirm the diagnosis. studies show variations in oncological outcomes based on the subgroups of kidney cancer treated with ablative techniques. ablative techniques seem to have a lower risk of complications compared to surgery concerning perioperative complications, bleeding, and maintaining kidney function for a longer time. however, there are no randomized controlled studies comparing ablative treatment with nephrectomy for t1a tumors in the kidney. 3. hypothesis ablative treatment of small kidney tumors may result in shorter hospital stays with fewer complications compared to surgical resection. there is no difference in long-term oncological outcomes between the methods. 4. outcome measures the primary purpose of the study is to compare surgical complications, findings of remaining tumors after primary treatment, and the time patients are hospitalized after each procedure. secondary outcomes include oncological outcomes in the short and long term, as well as functional factors

Eligibility criteria:
inclusion criteria: * age 18 - 99 years * patient suitable based on clinical status for both ablative treatment and surgery * primary kidney tumor * tumor size ≤ 3 cm * clinical stage of the tumor t1a (no macroscopic vascular or extrarenal invasion) * tumor location suitable for both ablative treatment and resection * absence of radiological signs of metastasis * biopsy with malignant pathological analysis (pad) * isup grade i-iii" exclusion criteria: * radiological signs of metastasis * synchronous kidney tumors * isup grade iv or sarcomatoid growth in the biopsy * other metastasized cancer in the last 5 years * patient unable to make an informed decision to participate in the study
electrocorticographic monitoring of brain retraction injury (embri)

Conditions: Brain Injury; Neurosurgery; Brain Ischemia

Summary: a single centre ideal stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. this is a first in human study, building upon previous preclinical mice experiments. participants will undergo their planned neurosurgical procedure as normal. in addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.


Eligibility criteria:
inclusion criteria: * patients aged 16 or older undergoing intracranial surgery where it is anticipated fixed brain retraction will be used. exclusion criteria: * patients without capacity to give consent at time of recruitment

Keywords: brain retraction
effect of a probiotic formula on reducing sibo in ibs patients

Conditions: Irritable Bowel Syndrome; Small Intestinal Bacterial Overgrowth

Summary: this randomized study evaluates the effectiveness of the a probiotic formula, compared with the antibiotic rifaximin, in the treatment of small intestinal bacterial overgrowth (sibo) in irritable bowel syndrome (ibs) patients.

irritable bowel syndrome (ibs) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. disordered bowel habits are typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention. ibs pathophysiology is multifactorial and may include alterations of the gut microbiota, food intolerances and small intestinal bacterial overgrowth (sibo). however, sibo is a distinct entity than ibs, as patients can present sibo without ibs. sibo is diagnosed based on objective tests (breath test or microbial culture of duodenal aspirate) while ibs is a functional syndrome, diagnosed on symptoms (rome-iv criteria). a probiotic formula composed of strains pediococcus acidilactici cect 7483 and lactobacillus plantarum cect 7484 and cect 7485 was previously shown to improve quality of life in patients with ibs. rifaximin is a a non-absorbable antibiotic commonly used for the treatment of sibo.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ibs according to rome iv criteria (lacy et al. gastroenterology 2016) and with sibo according to north american consensus (rezaie et al., am j gastroenterol. 2017), providing informed consent. patients taking set doses of proton pump inhibitors (ppis) or antispasmodics can be included. exclusion criteria: * use of antibiotics in the 4 weeks before study initiation. * use of probiotics in the 2 weeks before study initiation. * use of loperamide or other prokinetics in the week before study initiation. * use of plantago ovata, lactulose or other laxans in the week before study initiation. * use of antidepressants. * suspicion or confirmed diagnose of coeliac disease, inflammatory bowel disease (ibd), symptomatic diverticulosis/diverticulitis, or endometriosis. * previous intestinal surgery, except appendectomy and herniorrhaphy. * short bowel syndrome or pancreatitis. * concomitant treatment with immunosuppressors, oncologic disease, severe cardiovascular disease, positive for hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv). * other conditions that can interfere with the effect of probiotic. * pregnant or lactating women.
therapeutic hypothermia in "expanded criteria" brain-dead donors and kidney-graft function

Conditions: Organ Donor; Brain Death; Kidney Transplant; Complications; Critical Illness; Hypothermia

Summary: each year, only one third of patients registered on the waiting list receive a kidney transplant. numerous paths are being explored with the aim of reversing this shortage. the first is to increase the number of organs by developing harvesting from donors in a state of brain-death (bd) termed "expanded criteria donors" or from patients deceased from circulatory arrest. another fundamental factor is to insure the success of the transplant by limiting the dysfunction of donor kidneys, marked by a delayed graft function (dfg). the development of techniques to insure correct perfusion of harvested organs, and the optimization of reanimation and intensive care of brain-dead donors constitute important factors in dgf reduction. therapeutic hypothermia could to be an attractive care strategy for bd patients.


Eligibility criteria:
inclusion criteria: * for donors: legal determination of death by neurologic criteria/deceased organ donor/no medical contre-indication to donation/information given to the authorizing surrogate/ pregnant women. * for transplant recipients : age 18 years or greater /information given and no opposition signed by recipients. exclusion criteria: * for donors: no legal determination of death by neurologic criteria/not a deceased organ donor/ medical contre-indication to donation/ no information given to the authorizing surrogate. * for transplant recipients: age \<18 years / no information given and/or opposition signed by recipients.
the secondary beneficial effects of prostaglandin analog treatment in thyroid eye disease patients.

Conditions: Thyroid Eye Disease; Ocular Hypertension; Glaucoma

Summary: the purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (pa) treatment in thyroid eye disease (ted) patients. this study aims to determine if pa would change the course of the orbitopathy in ted patients by altering the progression of the common features of ted, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. the eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the pa treatment and the other eye will serve as a control eye and will be treated with timolol.


Eligibility criteria:
inclusion criteria: * mild or moderate to severe thyroid eye disease in one or both eyes * age \> 18 years * informed consent * intraocular pressure \> 21 mmhg or glaucoma suspect or glaucoma diagnosed in one or both eyes * not on current prostaglandin analog intraocular pressure lowering therapy exclusion criteria: * sight threatening thyroid eye disease * children \< 18 years old * patients that are not compliant with treatment or follow-up * patients already on prostaglandin analog treatment * patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up * patients that cannot tolerate prostaglandin analog treatment. * patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.

Keywords: thyroid eye disease graves' disease prostaglandin analogues
factor viia in acute intracerebral haemorrhage

Conditions: Acquired Bleeding Disorder; Intracerebral Haemorrhage

Summary: this trial is conducted in japan. the purpose of this trial is to evaluate the safety and preliminary efficacy of activated recombinant factor vii (nn-007) in patients with acute intracerebral haemorrhage.


Eligibility criteria:
inclusion criteria: * spontaneous ich exclusion criteria: * time of ich onset \> 3 hours * patients with secondary ich * pre-existing disability * hemophilia
a study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of abp-671 in healthy subjects

Conditions: Gout; Hyperuricemia

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of abp-671 administered orally in healthy volunteers.

primary objectives: • to assess the safety and tolerability of single ascending oral doses of abp-671 in healthy volunteers (hvs). secondary objectives: • to characterize the pharmacokinetics (pk) and pharmacodynamics (pd) profiles of single ascending oral doses of abp-671 in hvs.

Eligibility criteria:
inclusion criteria 1. healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ecg, and vital signs. 2. participants serum uric acid level at screening ≥ 4.0 mg/dl to ≤ 5.5 mg/dl for males, and ≥ 4.0 mg/dl to ≤ 5.0 mg/dl for females. 3. participants must have a body mass index (bmi) between 18 and 32 kg/m2 and a body weight of 50 kg or higher. 4. participants must have normal blood chemistry or results considered not clinically significant by the investigator including electrolytes, alkaline phosphatase, total protein, albumin, aspartate aminotransferase (ast), alanine aminotransferase (alt), total bilirubin, uric acid, creatinine, blood urea nitrogen (bun), and glucose at screening visit and at pre-dose visit. 5. participants are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study. exclusion criteria 1. participants with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders. 2. participants who have any history or suspicion of kidney stones. 3. participants who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before day 1 of study medication dosing. females who have received hormone replacement therapy (hrt) within 28 days prior to dosing. 4. women who are pregnant or breastfeeding.

Keywords: gout hyperuricemia
dhea bioavailability following administration of vaginal suppositories in post-menopausal women with vaginal atrophy

Conditions: Vaginal Atrophy

Summary: the purpose of the study is to evaluate the systemic bioavailability of dhea and its metabolites and the pharmacokinetics of vaginal suppositories at four different dhea concentration.

humans, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (dhea) and especially its sulfate dhea-s. the marked reduction in the formation of dhea-s by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. much attention has been given to the benefits of dhea administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid. therefore, this study proposes to evaluate the systemic bioavailability and the effectiveness of 1.3 ml vaginal suppositories of dhea at 4 different concentrations (0.0%, 0.5%, 1.0% et 1.8%) following 1 week administration of vaginal suppositories in post-menopausal women with vaginal atrophy. this is a phase i, randomized, placebo-controlled, double-blind study.

Eligibility criteria:
inclusion criteria: * postmenopausal women, * experiencing one symptom of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity, * women having a low maturation index and a vaginal ph above 5, * endometrial thickness of 4 mm or less at transvaginal ultrasonography, * body weight within 18.5 and 32.0 according to body mass index. exclusion criteria: * undiagnosed abnormal genital bleeding, * active or history of thromboembolic disease, * significant metabolic or endocrine disease, * significant complication on previous hormonal therapy, * use of hormonal implants within 6 months prior to study entry, * use of oral estrogen, progestin or dhea in the 8 weeks prior to baseline, * use of natural (phytoestrogens) or herbal products in the 2 weeks prior to baseline, * chronic use of corticosteroids, * hypertension not controlled by standard therapy.

Keywords: vaginal atrophy dhea prasterone menopause
a comparison of epidural block with adding sciatic block to continuous femoral block in total knee arthroplasty

Conditions: Postoperative Pain

Summary: the investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. the primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices.

the parcicipants were randomly assingned to epidural infusion group and femoral sciatic block. in epidural infusion group, a lumbar epidural catheter was placed at the l3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation. in femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. a catheter is inserted to femoral nerve. from the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. the incidence of side effects is measured.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status classification i-ii * total knee arthroplasty * 18-90 years exclusion criteria: * allergic to the local anesthetics * cognitive impairment such as dementia * coagulopathy * motor and sensory impairment * patient refusal * bmi \>39
single patient expanded access treatment plan for the investigational product narsoplimab

Conditions: Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)

Summary: the purpose of the eap is to provide access to hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma) patients who may benefit from treatment with narsoplimab based on the medical judgement of their respective physicians.


Eligibility criteria:
* patient (adult or pediatric) must have undergone allogeneic or autologous hematopoietic stem cell transplant (hsct) * patient must be capable of understanding an informed consent form (icf) or the parent or legal guardian of the patient is able to understand and sign a written icf prior to the initiation of any treatment procedures. * patient must have hsct- tma defined as having thrombocytopenia and evidence of microangiopathic hemolytic anemia.
behavioral intervention for prep service utilization among chinese msm: a hapa and cei integrated model

Conditions: HIV; PrEP; MSM; Behavior Changes

Summary: the goal of this clinical trial is to evaluate the effectiveness of a novel, intelligent intervention platform in bridging the "intention-behavior gap" for pre-exposure prophylaxis (prep) uptake among men who have sex with men (msm) in china, a population at high risk for hiv infection. the study aims to address the following main questions: * can the intervention platform, guided by the health action process approach (hapa) and conditional economic incentive (cei) dual-track theoretical framework, significantly increase prep initiation rates among msm? * what are the key mechanisms and pathways underlying the transition from prep intention to actual usage behavior? researchers will compare participants receiving the intelligent intervention platform (intervention group) with those receiving basic prep information (control group) to determine the platform's impact on prep initiation rates. participants will: * use a mobile health platform equipped with personalized hiv risk assessments, prep knowledge resources, action planning tools, peer support features, and economic incentives. * complete baseline and follow-up surveys at 3 months and 6 months to assess prep initiation, adherence, and related behaviors. * engage in peer group activities and receive tailored feedback based on their progress. this study seeks to provide evidence for scalable and sustainable strategies to improve prep uptake and contribute to hiv prevention efforts in high-risk populations.


Eligibility criteria:
inclusion criteria: * ≥18 years at enrollment; * assigned male at birth with a history of ≥1 male-male sexual encounter (anal or oral intercourse); * hiv-negative confirmed by antibody testing at baseline; * no prior use of prep; * expressed interest in prep intervention and commitment to complete scheduled follow-ups and data collection procedures; * mentally competent to provide informed consent and participate in decision-making; * high hiv risk (meeting ≥1 of the following in the past 6 months): (1) condomless anal/penile-vaginal intercourse; (2)shared needle use during illicit drug injection; (3) sexual contact with hiv-positive partner(s); (4) newly diagnosed sti; (5) repeated use of pep for hiv prevention; or (6) self-identified as prep candidate through voluntary request. exclusion criteria: * confirmed hiv-positive status or unknown serostatus with refusal of hiv testing; * clinically significant health conditions contraindicating prep use (e.g., creatinine clearance \<60 ml/min, documented hypersensitivity to prep components); * severe mental illness or neurological disorders impairing informed consent process.

Keywords: hiv pre-exposure prophylaxis men who have sex with men health action process approach economic incentive